BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M.U.S.T. MIDLINE CORTICAL (MC) SCREW SYSTEM

    MDR report key: 22520976 · Received July 16, 2025

    Report

    Report Number
    3005180920-2025-00656
    Event Type
    Malfunction
    Date Received
    July 16, 2025
    Date of Event
    June 25, 2025
    Report Date
    July 16, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    NKB
    UDI-DI
    07630971293465
    PMA / PMN Number
    K210427
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 30 JUNE 2025. LOT 2463010: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15/10/2024. EXPIRATION DATE: 25/09/2029. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. OTHER DEVICE INVOLVED: MYSPINE 7.0723 MYSPINE-MC DRILL GUIDE L03 (K173472) LOT 17218S: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02/052025. EXPIRATION DATE: 2025/10/24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. PATIENT MATCH PLANNING REVIEW: OUR ANALYSIS OF THE MYSPINE PROCESS OF THIS CASE FOUND NO DEVIATIONS FROM THE STANDARD PROCEDURES. EACH STEP HAS BEEN PERFORMED CORRECTLY. WE HAVE REPRODUCED ALL GUIDES WITH THEIR BONE MODEL, IN ORDER TO CHECK THE FITTING AGAIN. WE CAN CONFIRM THE STABILITY AND CONFORMITY OF THE GUIDES. CLINICAL EVALUATION: A PLIF SURGERY AT LEVELS L3-L5 WAS PERFORMED UTILIZING PATIENT-MATCHED GUIDES FOR SCREW POSITIONING. ACCORDING TO THE SURGICAL REPORT, THE GUIDE AT THE L3 LEVEL WAS POSITIONED CAREFULLY. HOWEVER, THE POSTOPERATIVE CT REVEALED INCORRECT PLACEMENT OF BOTH THE LEFT AND RIGHT SCREWS, WHICH RESULTED OUT OF THE BONE. CURRENTLY, THE PATIENT REMAINS ASYMPTOMATIC, AND NO DECISION REGARDING REVISION SURGERY HAS BEEN MADE AT THIS TIME. THE ANALYSIS CONDUCTED BY THE PATIENT-MATCHED GUIDE DEPARTMENT REVEALED NO PROCEDURAL ERRORS DURING THE MANUFACTURING OR PLANNING PHASES. THUS, IT IS REASONABLE TO CONCLUDE THAT THE EVENT MAY BE ATTRIBUTABLE TO FACTORS RELATED TO THE INTRAOPERATIVE POSITIONING OF THE GUIDE, INCOMPLETE PREPARATION OF THE BONE FOR GUIDE POSITIONING, OR ANATOMICAL CHANGES IN THE BONE STRUCTURE THAT OCCURRED IN THE INTERVAL BETWEEN THE PREOPERATIVE CT SCAN AND THE ACTUAL SURGERY. WHILE A DEFINITIVE ROOT CAUSE COULD NOT BE ESTABLISHED, THE INVESTIGATION DID NOT IDENTIFY ANY DEVIATIONS OR ANOMALIES IN THE DEVICE USED, THE PLANNING PROTOCOL, OR THE MANUFACTURING OF THE PATIENT-SPECIFIC GUIDES. THE INCIDENT IS POTENTIALLY ATTRIBUTABLE TO INTRAOPERATIVE VARIABLES, SUCH AS SUBOPTIMAL GUIDE PLACEMENT OR BONE PREPARATION, OR ANATOMICAL VARIATIONS OF THE BONE STRUCTURE THAT MAY HAVE ARISEN BETWEEN THE PREOPERATIVE CT ACQUISITION AND THE SURGICAL PROCEDURE.

    Description of Event or Problem · 0

    PLIF SURGERY WAS PERFORMED AT L3-L5 WITH THE MYSPINE MC GUIDE ON (B)(6) 2025. THE DAY AFTER THE SURGERY, CT SCAN WAS TAKEN AND IT APPEARED THAT THE ENTIRE GUIDE HAD BEEN PLACED TILTED TO THE LEFT (MEANING THAT THE TRAJECTORY OF THE SCREWS ARE VERY DIFFERENT FROM THE PLANNING). NO FITTING ISSUE WITH THE GUIDES WAS EXPERIENCED DURING SURGERY. THE PATIENT IS CURRENTLY ASYMPTOMATIC, AND THE SURGEON IS CURRENTLY WAITING FOR THE BONE FUSION. WEAK BONE QUALITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    151392 M.U.S.T. MIDLINE CORTICAL (MC) SCREW SYSTEM PEDICLE SCREW 03.58.234 MUST MC SCREW Ø5.5X40 CANNULATED NKB MEDACTA INTERNATIONAL SA 03.58.234 2463010 07630971293465

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female Other